TTFields科研社区

TTFields and Radiosurgery of Recurrent Glioblastoma +/- 18F-Fluoro-Ethyl-Thyrosine, The Franciszek Lukaszczyk Oncology CenterBydgoszcz, Poland. Detailed Description:Almost all GBM patients experience recurrent disease. Stereotactic radiosurgery (SRS),at recurrence, has limitations due to the invasive nature of glioblastoma. TTFields may decrease the tumor aggressiveness outside the target area potentially by multiple pathways, including immunogenic cell death and DNA repair inhibition sensitizing to radiation. We hypothesize that combined SRS and TTFields will be complementary, improving outcomes with minimal toxicity.In this open-label, phase II trial 40 participants with recurrence will be treated with SRS and TTFields, starting in 2020. Recurrence will be defined on FET-PET or MRI using RANO criteria.All patients will begin treatment within 14 days from baseline imaging evaluation and at maximum 42 days from screening.The attempt to obtain the Methyl-guanine methyl-transferase (MGMT) gene promoter methylation and IDH1 and IDH2 mutation from primary tumor are made during the study whenever not defined before entering to the study.TTFields treatment will be initiated as in clinical routine at patients home. Admission to hospital will not be necessary.SRS must be delivered within 7 days of TTFields start. A 5-day SRS regimen is allowed. TTFields should be interrupted only during SRS. The sample size of the study was calculated for the comparison of survival against a historical control.Overall survival will be stratified by volume, PET-based treatment, SVZ invasion, MGMT methylation status, time to first progression, and TTFields compliance. 【复发性胶质母细胞瘤+/-18F氟乙基甲状腺素的治疗与放射外科，波兰弗朗西斯泽克卢卡斯茨克肿瘤中心。详细数据元素描述：几乎所有GBM患者经历复发性疾病。由于胶质母细胞瘤的侵袭性，立体定向放射外科（SRS）在复发时具有局限性。TTFields可能通过多种途径降低肿瘤在靶区外的侵袭性，包括免疫原性细胞死亡和对辐射敏感的DNA修复抑制。我们假设SRS和TTFields的结合将是互补的，以最小的代价改善结果，从2020年开始。40名复发患者将接受SRS和TTFields治疗。使用RANO在FET-PET或MRI上确定复发标准。全部患者将在基线影像学评估后14天内开始治疗，最多42天开始治疗筛选本研究尝试从原发性肿瘤中获得甲基鸟嘌呤甲基转移酶（MGMT）基因启动子甲基化和IDH1、IDH2突变在进入研究.TTFields治疗将在患者家中按照临床常规开始。不允许入院必要的SRS必须在开工后7天内交货。一个5天的SRS方案是允许的。TTFields只能在SRS期间中断。研究样本量的计算是为了将生存率与历史数据进行比较总体控制生存率将根据容积、PET治疗、SVZ侵袭、MGMT甲基化状态、首次进展时间和TTF依从性进行分层。】